Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005533818

FEI Number

3005533818

Entity Name

PROSYS INTERNATIONAL LTD

City/State/Country

London London, City of, GB

Establishment Address

Suite 4, 2 Allington Close; Wimbledon; England, London London, City of SW19 5AP, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Prosys International Ltd (Owner Number: 10048819)

Owner / Operator Contact Address

Suite 4, 2 Allington Close, Wimbledon, GB-ENG SW19 2AP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193325

PMA Number

N/A

All Registered Proprietary Names

Offload Bootee Prevasse Avantgarde +T

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2022-04-28
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2022-04-28
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2021-07-02

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Prosys International Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Similar Registrations

Registration Number	Establishment Name	Location
3004632523	Eduard Gerlach Gmbh	Luebbecke North Rhine-Westphalia, DE
3038624835	DONGGUAN HEECOOL TECHNOLOGY CO., LTD.	Dongguan Guangdong, CN
3010364377	Flexor SA	Barbera del Valles Barcelona, ES
3016232365	SHENZHEN FOAMTECH CO., LTD	Shenzhen Guangdong, CN
2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005533818. Last updated year: 2026. Please use registration number 3005533818 when referencing this establishment in official correspondence.